Comparison of Screening Tests in Detecting Cervical Neoplasia
NCT ID: NCT00039312
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
1999-12-31
2010-04-30
Brief Summary
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PURPOSE: Screening trial to compare different types of screening tests used to detect cervical neoplasia.
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Detailed Description
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* Compare the sensitivity and specificity of primary screening strategies for the detection of cervical intraepithelial or invasive neoplasia.
* Compare the positive and negative predictive values of these strategies.
OUTLINE: This is a multicenter study. Patients are stratified according to the reason for the visit (general gynecological screening vs colposcopy referral).
* Stratum 1 (general gynecological screening): Patients undergo Pap smear, visual inspection aided by acetic acid (VIA), a colposcopy, and finally a visual inspection aided by toluidine blue (VIT) followed by an acetic acid wash. A biopsy may be performed at this initial visit. Within 2-3 weeks, patients are notified of results.
* Stratum 2 (colposcopy referral): Patients undergo Pap smear, VIA, colposcopy, VIT, and possible biopsy as in stratum 1. During the same visit, patients receive histologic evaluation and treatment with See-and-Treat loop electrosurgical excision procedure and/or endocervical curettage.
PROJECTED ACCRUAL: A total of 600-1,000 patients (300-500 per stratum) will be accrued for this study.
Conditions
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Study Design
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SCREENING
Interventions
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Papanicolaou test
cytology specimen collection procedure
annual screening
colposcopic biopsy
comparison of screening methods
Eligibility Criteria
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Inclusion Criteria
* Presenting for a well-woman visit, annual Pap smear, or family planning
* Other gynecological or non-gynecological complaints allowed OR
* Referred for colposcopy secondary to an abnormal Pap smear
* Planned screening for cervical cancer
* Over 18 years of age
* Prior laser surgery, cryotherapy, or conization or loop electrosurgical excision procedure for cervical neoplasia allowed
Exclusion Criteria
* pregnant
* prior hysterectomy
* concurrent anticoagulants
18 Years
FEMALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Christine Holschneider, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Locations
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Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Countries
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Other Identifiers
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UCLA-9910034
Identifier Type: -
Identifier Source: secondary_id
NCI-G02-2076
Identifier Type: -
Identifier Source: secondary_id
99-10-034
Identifier Type: -
Identifier Source: org_study_id
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